Effects of intensive glucose lowering in type 2 diabetes. Export

@article{citeulike:2881049, abstract = {BACKGROUND: Epidemiologic studies have shown a relationship between glycated hemoglobin levels and cardiovascular events in patients with type 2 diabetes. We investigated whether intensive therapy to target normal glycated hemoglobin levels would reduce cardiovascular events in patients with type 2 diabetes who had either established cardiovascular disease or additional cardiovascular risk factors. METHODS: In this randomized study, 10,251 patients (mean age, 62.2 years) with a median glycated hemoglobin level of 8.1\% were assigned to receive intensive therapy (targeting a glycated hemoglobin level below 6.0\%) or standard therapy (targeting a level from 7.0 to 7.9\%). Of these patients, 38\% were women, and 35\% had had a previous cardiovascular event. The primary outcome was a composite of nonfatal myocardial infarction, nonfatal stroke, or death from cardiovascular causes. The finding of higher mortality in the intensive-therapy group led to a discontinuation of intensive therapy after a mean of 3.5 years of follow-up. RESULTS: At 1 year, stable median glycated hemoglobin levels of 6.4\% and 7.5\% were achieved in the intensive-therapy group and the standard-therapy group, respectively. During follow-up, the primary outcome occurred in 352 patients in the intensive-therapy group, as compared with 371 in the standard-therapy group (hazard ratio, 0.90; 95\% confidence interval [CI], 0.78 to 1.04; P=0.16). At the same time, 257 patients in the intensive-therapy group died, as compared with 203 patients in the standard-therapy group (hazard ratio, 1.22; 95\% CI, 1.01 to 1.46; P=0.04). Hypoglycemia requiring assistance and weight gain of more than 10 kg were more frequent in the intensive-therapy group (P<0.001). CONCLUSIONS: As compared with standard therapy, the use of intensive therapy to target normal glycated hemoglobin levels for 3.5 years increased mortality and did not significantly reduce major cardiovascular events. These findings identify a previously unrecognized harm of intensive glucose lowering in high-risk patients with type 2 diabetes. (ClinicalTrials.gov number, NCT00000620.)}, author = {{Action to Control Cardiovascular Risk in Diabetes Study Group} and Gerstein, Hertzel C. and Miller, Michael E. and Byington, Robert P. and Goff, David C. and Bigger, J. Thomas and Buse, John B. and Cushman, William C. and Genuth, Saul and Ismail-Beigi, Faramarz and Grimm, Richard H. and Probstfield, Jeffrey L. and Simons-Morton, Denise G. and Friedewald, William T.}, citeulike-article-id = {2881049}, citeulike-linkout-0 = {http://dx.doi.org/10.1056/NEJMoa0802743}, citeulike-linkout-1 = {http://content.nejm.org/cgi/content/abstract/358/24/2545}, citeulike-linkout-2 = {http://view.ncbi.nlm.nih.gov/pubmed/18539917}, citeulike-linkout-3 = {http://www.hubmed.org/display.cgi?uids=18539917}, day = {12}, doi = {10.1056/NEJMoa0802743}, issn = {1533-4406}, journal = {The New England journal of medicine}, keywords = {diabetes, glucose, low}, month = {June}, number = {24}, pages = {2545--2559}, posted-at = {2009-02-09 20:11:16}, priority = {2}, title = {Effects of intensive glucose lowering in type 2 diabetes.}, url = {http://dx.doi.org/10.1056/NEJMoa0802743}, volume = {358}, year = {2008} }

TY - JOUR ID - citeulike:2881049 L3 - citeulike-article-id:2881049 N2 - BACKGROUND: Epidemiologic studies have shown a relationship between glycated hemoglobin levels and cardiovascular events in patients with type 2 diabetes. We investigated whether intensive therapy to target normal glycated hemoglobin levels would reduce cardiovascular events in patients with type 2 diabetes who had either established cardiovascular disease or additional cardiovascular risk factors. METHODS: In this randomized study, 10,251 patients (mean age, 62.2 years) with a median glycated hemoglobin level of 8.1% were assigned to receive intensive therapy (targeting a glycated hemoglobin level below 6.0%) or standard therapy (targeting a level from 7.0 to 7.9%). Of these patients, 38% were women, and 35% had had a previous cardiovascular event. The primary outcome was a composite of nonfatal myocardial infarction, nonfatal stroke, or death from cardiovascular causes. The finding of higher mortality in the intensive-therapy group led to a discontinuation of intensive therapy after a mean of 3.5 years of follow-up. RESULTS: At 1 year, stable median glycated hemoglobin levels of 6.4% and 7.5% were achieved in the intensive-therapy group and the standard-therapy group, respectively. During follow-up, the primary outcome occurred in 352 patients in the intensive-therapy group, as compared with 371 in the standard-therapy group (hazard ratio, 0.90; 95% confidence interval [CI], 0.78 to 1.04; P=0.16). At the same time, 257 patients in the intensive-therapy group died, as compared with 203 patients in the standard-therapy group (hazard ratio, 1.22; 95% CI, 1.01 to 1.46; P=0.04). Hypoglycemia requiring assistance and weight gain of more than 10 kg were more frequent in the intensive-therapy group (P<0.001). CONCLUSIONS: As compared with standard therapy, the use of intensive therapy to target normal glycated hemoglobin levels for 3.5 years increased mortality and did not significantly reduce major cardiovascular events. These findings identify a previously unrecognized harm of intensive glucose lowering in high-risk patients with type 2 diabetes. (ClinicalTrials.gov number, NCT00000620.) IS - 24 JF - The New England journal of medicine SN - 1533-4406 EP - 2559 TI - Effects of intensive glucose lowering in type 2 diabetes. VL - 358 SP - 2545 KW - diabetes KW - glucose KW - low AU - Gerstein, Hertzel AU - Miller, Michael AU - Byington, Robert AU - Goff, David AU - Bigger, Thomas AU - Buse, John AU - Cushman, William AU - Genuth, Saul AU - Ismail-Beigi, Faramarz AU - Grimm, Richard AU - Probstfield, Jeffrey AU - Simons-Morton, Denise AU - Friedewald, William PY - 2008/06/12/ UR - http://dx.doi.org/10.1056/NEJMoa0802743 ER -